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New treatment option for Nasopharyngeal Carcinoma
Official title De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06313450
What this study is testing
- What it's testing
- In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Pathologically confirmed nasopharyngeal carcinoma, patients who have not received anti-cancer therapy;
- ECOG performance status score (PS score) 0 or 1.
- 18-70 years old.
- Stage II-III except T2N0M0 (AJCC 8th).
- Neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 90 g/L and platelet count ≥ 100 × 10\^9/L.
You likely can't join if
- Patients will be excluded from the study, if any of the following criteria is met:
- Over the age of 70 or under the age of 18.
- HBsAg positive and HBV DNA ≥ 1 × 10\^3 copies/ml
- HCV antibody positive.
- people with active, known or suspected autoimmune diseases were excluded from the study. Eligible participants included those with type 1 diabetes...
- History of interstitial lung disease;
See the full eligibility criteria
- Pathologically confirmed nasopharyngeal carcinoma, patients who have not received anti-cancer therapy;
- ECOG performance status score (PS score) 0 or 1.
- 18-70 years old.
- Stage II-III except T2N0M0 (AJCC 8th).
- Neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 90 g/L and platelet count ≥ 100 × 10\^9/L.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), bilirubin ≤ 1.5 times ULN; Creatinine clearance ≥ 60 ml/min
- Patients are required to sign an informed consent form and must be willing and able to comply with the visits, treatment plan, laboratory tests, and other requirements specified in the study protocol
- Patients will be excluded from the study, if any of the following criteria is met:
- Over the age of 70 or under the age of 18.
- HBsAg positive and HBV DNA ≥ 1 × 10\^3 copies/ml
- HCV antibody positive.
- people with active, known or suspected autoimmune diseases were excluded from the study. Eligible participants included those with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and...
- History of interstitial lung disease;
- Receiving systemic sex hormones or other immunosuppressive therapy at equivalent doses ≥ 10 mg prednisone/day within 28 days prior to signing informed consent; people with systemic sex hormone doses ≤ 10 mg...
- Received or about to receive live vaccines within 30 days before signing the informed consent form;
- Pregnant or lactating women;
- Other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer;
- Known previous hypersensitivity to macromolecular protein preparations, or to any component of Toripalimab;
- Human immunodeficiency virus (HIV) infection.
- Other conditions that may affect the safety of people or trial compliance as judged by the investigator, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.